Registration Dossier
Registration Dossier
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EC number: 926-540-5 | CAS number: 1174510-13-4
Acute Toxicity: oral
Administrative data
- Endpoint:
- acute toxicity: oral
- Type of information:
- migrated information: read-across from supporting substance (structural analogue or surrogate)
- Adequacy of study:
- supporting study
- Study period:
- 1996
- Reliability:
- 2 (reliable with restrictions)
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 996
- Report date:
- 1996
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 401 (Acute Oral Toxicity)
- GLP compliance:
- yes
- Test type:
- standard acute method
- Limit test:
- yes
Test material
- Reference substance name:
- ACIDE IOXITALAMIQUE 95
- IUPAC Name:
- ACIDE IOXITALAMIQUE 95
- Test material form:
- solid: particulate/powder
- Remarks:
- migrated information: powder
- Details on test material:
- No toxicology data are available on the substance "95SA", also called "ioxitalamic acid, ammonium salt". However, data are available on the substance "95" (also called "ioxitalamic acid") and, therefore, the Applicant proposes to rely on these data. The chemical structure of both substances is the same, but "95SA" is an ammonium salt of "95". The quality (purity) of both substances is also comparable as "95SA" has a slightly higher total impurity content than "95" (total impurities < 2% in "95SA", while < 1% in "95"). It is not believed that these 2 minor differences may alter dramatically the toxicity profile established for "95". It is also of importance to know that "95" is a well-characterized pharmaceutical active substance, authorised in drug product called Telebrix.
Therefore, the data on "95" are considered fully relevant to assess the toxicity profile of "95SA".
Constituent 1
Test animals
- Species:
- rat
- Strain:
- Sprague-Dawley
- Sex:
- male/female
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- water
- Doses:
- 2000 mg/kg at 5 ml/kg
- No. of animals per sex per dose:
- 5
- Control animals:
- not specified
Results and discussion
Effect levels
- Sex:
- male/female
- Dose descriptor:
- LD0
- Effect level:
- >= 2 000 mg/kg bw
- Based on:
- test mat.
- Mortality:
- No mortality observed after 14d.
- Clinical signs:
- other: No clinical signs observed after 14d.
- Gross pathology:
- No gross pathology observed after 14d.
Applicant's summary and conclusion
- Interpretation of results:
- not classified
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- Upon directive 67/548, substance acide ioxitalamique is not classified as a dangerous substance.
Information on Registered Substances comes from registration dossiers which have been assigned a registration number. The assignment of a registration number does however not guarantee that the information in the dossier is correct or that the dossier is compliant with Regulation (EC) No 1907/2006 (the REACH Regulation). This information has not been reviewed or verified by the Agency or any other authority. The content is subject to change without prior notice.
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